BRIEFING

  〈1221〉 Ongoing Procedure Performance Verification. This new chapter on ongoing procedure performance verification (OPPV) is an essential component (Stage 3) of the framework outlined in Analytical Procedure Life Cycle 〈1220〉. OPPV is designed to ensure the reliable performance of analytical procedures during their routine use, confirming they consistently meet predefined analytical target profile (ATP) criteria. OPPV can also be performed if an ATP has not been defined where verification criteria can be derived using existing knowledge. OPPV differs from routine procedure control through its proactive monitoring approach. It systematically collects and analyzes data to detect performance issues or adverse trends, ensuring timely corrective actions to prevent significant deviations. This extends to potential improvements drawn from accumulated knowledge which also supports platform analytical procedures. This chapter encourages an integrated approach to managing and improving analytical procedures with a balanced effort, ensuring product safety and efficacy alongside business efficiency. The alignment with existing control strategies can significantly benefit analytical scientists engaging in analytical procedure enhancements and risk management. The USP Measurement and Data Quality Expert Committee, in collaboration with the USP Statistics Expert Committee, acknowledges that life cycle concepts will continue to evolve as ICH Q2(R2), ICH Q12, and ICH Q14 are implemented across the pharmaceutical industry. USP 〈1221〉 will be reviewed going forward to ensure alignment with ICH implementation best practices.

 (GCMDQ: A. Hernandez-Cardoso)

 Case ID—SUB-2136